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30 May 2026: MediLink Therapeutics announces B7-H3 ADC YL201 met primary endpoint in phase 3 Nasopharyngeal carcinoma study
- MediLink Therapeutics has announced that its B7-H3-targeted ADC YL201, successfully met the primary endpoint in a pivotal phase 3 TAISHAN-301 trial for recurrent or metastatic nasopharyngeal carcinoma, marking a major clinical milestone for the program and reinforcing the growing potential of B7-H3-targeted therapies in solid tumors
- This phase 3 trial demonstrated a statistically significant and clinically meaningful improvement in efficacy versus standard treatment, supporting YL201’s potential to address a significant unmet need in patients with advanced NPC who have limited treatment options following disease progression
- YL201 is a next-generation B7-H3-directed ADC developed using MediLink’s proprietary TMALIN platform, which is designed to enhance tumor-selective payload release, improve therapeutic window, and maximize anti-tumor activity across multiple solid tumor types
- Beyond nasopharyngeal carcinoma, YL201 is being evaluated in two ongoing phase 3 registration studies spanning SCLC, and ESCC, reflecting the expanding clinical utility of the B7-H3 target, capable of reshaping treatment paradigms across multiple difficult-to-treat cancers while intensifying competition in the next wave of solid tumor ADC development
- Strategically, the phase 3 success strengthens MediLink’s position in the increasingly competitive B7-H3 ADC landscape, validates its proprietary linker technology, and enhances the value of its global partnership with Roche as the companies pursue broader commercialization opportunities across multiple solid tumor indications
